Official Title
Immunogenicity and Safety of Commercially Available Vaccines Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients With Hematologic Malignancies and Associated Precursor Conditions
Brief Summary

D1. Primary Objective: 1. Determine the immunogenicity of FDA approved COVID-19 vaccination in patients with hematologic malignancies D2. Secondary Objectives: 1. Assess the safety of FDA approved COVID-19 vaccination in patients with hematologic malignancies 2. Analyze the kinetics of immunogenic response over time after receipt of the COVID-19 vaccination 3. Compare the immunogenicity of different COVID-19 vaccinations that will be approved by the FDA 4. Analyze advanced flow immunophenotyping of innate and adaptive immune blood cells in all participants and correlate with response to vaccination

Completed
Monoclonal B-Cell Lymphocytosis
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
B-cell Non Hodgkin Lymphoma
Hodgkin Lymphoma
Eligibility Criteria

Inclusion Criteria:

1. Patients must not have received any prior COVID-19 vaccination

2. Patients must have any one of the following diagnosis:

a. Monoclonal B-cell lymphocytosis b. Chronic lymphocytic leukemia/small lymphocytic
lymphoma c. B-cell Non-Hodgkin's lymphoma: i. Follicular lymphoma ii. Mantle cell
lymphoma iii. Diffuse large B-cell lymphoma iv. Marginal zone lymphoma v. Burkitt
lymphoma vi. Double hit/triple hit lymphoma vii. Lymphoplasmacytic
lymphoma/Waldenstrom's macroglobulinemia d. Hodgkin lymphoma

Exclusion Criteria:

1. Receipt of any vaccination (e.g., influenza, recombinant zoster) 2 weeks prior to
registration

2. Prior chemotherapy, immunotherapy or oral agent therapy that was completed >12 months
prior to enrollment. NOTE: patients who are on oral agents for the treatment of their
underlying malignancy will be allowed. Some of these medication classes include Bruton
tyrosine kinase inhibitor (BTKi), BCL2 antagonists, PI3 kinase inhibitors,
immunomodulatory agents, among others. Please contact the Principal Investigator for
any clarification about these medications.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Mayo Clinic
Rochester, Minnesota, United States

Sameer Parikh, M.B.B.S., Principal Investigator
Mayo Clinic

NCT Number
Keywords
Lymphoma
COVID-19 vaccine
CLL
MeSH Terms
Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Hematologic Neoplasms
Lymphoma, B-Cell
Lymphocytosis